Suspected statin-related adverse drug reactions: analysis of spontaneous reports in Hubei Province, China (2014-2022).

Introduction: Statins, some of the most widely prescribed medications for the treatment of cardiovascular diseases, cause common and serious adverse drug reactions (ADRs). However, studies of statin-related ADRs in the Chinese population are lacking.

Research design and methods: ADR reports of statins collected by the Hubei Adverse Drug Reaction Monitoring Center from 2014 to 2022 were analyzed. Statin safety was described using descriptive analysis and three signal mining methods: reporting odds ratio, proportional reporting ratio, and a combined standard method.

Results: ADRs were common in individuals aged 50-79 years. Most administration routes are oral. ADR reports of atorvastatin and rosuvastatin were numerous and serious. The reports mainly consisted of gastrointestinal disorders, hepatobiliary disorders. Three signal mining algorithms generated 91 identical drug - event combination signals, including 23 off-label ADRs.

Conclusions: Atorvastatin was associated with a higher number of ADR reports and a higher proportion of serious ADRs than the other statins. Atorvastatin may cause off-label ADRs such as back pain, increased blood bilirubin, bone pain, hemorrhage, hepatic failure, and hepatocellular injury. Drug instructions should be enriched for better labeling of ADRs.